Johnson & Johnson Faulted by FDA for Defective Insulin Pumps

Personal-care-product giant Johnson & Johnson (J&J) was recently
on the receiving end of a scathing letter from the U.S. Food and Drug
Administration about faulty insulin pumps. The FDA reportedly questioned
why J&J's Animas unit continued to make and sell to consumers
a certain insulin pump even after knowing that design problems to the
keypad had caused product malfunctions.

The pumps in question are the 2020 and the One Touch Ping.

In its Dec. 27 letter, the agency apparently warned J&J that an inadequate
response to the
defective medical devices could bring fines or make J&J ineligible for federal contracts. The
letter also requested information about internal quality oversight. J&J
had 15 days to respond to the charges.

According to the FDA, J&J had started an internal investigation in
April. The agency further faulted the company for reporting injuries related
to pump use too slowly, and for not having a system in place for gathering
information about problems outside the U.S.

J&J has been heavily sanctioned by the FDA over the past couple of
years for faulty medical products. For example, the company had to
recall "dozens" of nonprescription medications; it sold defective hip replacements; and the FDA stepped in to increase
supervision of some of J&J's manufacturing operations.

Publicly J&J has committed to regulatory compliance and high quality.
Apparently, for the pump in question, the company has changed the design
feature of concern, worked to assess associated danger and risk, and switched
to a new supplier.

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